Clinical Trial Essentials; Implementation Best Practice: Two-Day Intensive GCP Course

By: Amer Alghabban, Managing Director, GxP Compliance and Training Partners (GCTP)
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Course Description:

This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP). Participants will acquire real-world application of GCP regulations and guidelines for critical elements of the clinical research and development process. This training includes the updates brought by the ICH E6 R2 Addendum.

During this interactive workshop, we will debate in what way clinical research team members can apply systems to achieve data integrity and quality through the trial lifecycle.

Specific attention will be given to how quality systems affect overall data integrity, patient clinical risk, and respective regulatory risk.

Learning Objectives:

  • Describe the elements of functional Quality Systems for Sponsors, Institutional Review Boards (IRBs), and Clinical Investigators
  • Identify the universal and local components of GCP
  • Explain the differences between the legal and procedural elements of GCP
  • Describe the overlap between GCP and Good Manufacturing Practice (GMP)
  • Recognize key differences in pharmaceutical, device, and biologics GCP
  • Examine recent trends in non-compliance
  • Develop and implement site-specific approaches for corrective action of non-compliance

Areas Covered:

  1. Principles of GCP: Different Perspectives: Examination; application; implementation
  2. New Developments and Emerging Trends in GCP
  3. The “Forgotten” Elements of GCP: Regulations; laws; guidelines
  4. Quality Systems: The Roadmap to GCP: Quality control; quality assurance; quality improvement
  5. Quality Risk Management (QRM) in Clinical Trials: Application of risk assessment in the review of protocols
  6. The Role of Standard Operating Procedures in GCP: Rationale; development; training; implementation; maintenance
  7. GCP Across Investigational Products: Drugs; devices; biologics
  8. Are We There Yet? Recent non-compliance issues with discussion of Corrective and Preventive Action planning

Who will Benefit:

This program is designed for professionals with two to three years of experience in the clinical research industry. Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP Focused Regulatory Affairs Professionals.

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.30 AM - 09.00 AM - Registration, Meet and Greet.
  • 09.00 AM - Session Start Time
  • Historical overview of Clinical Research
  • Observational studies
    • Case report
    • Case series
    • Cross section studies
    • Case control studies
    • Cohort studies
  • Phases of Clinical Development & Types of Clinical Trials
  • Planning and Initiating a Clinical Trial:
    • Role of the Sponsor:
      • Quality Assurance (QA) (see allocated time)
      • Contract Research Organizations (CROs)
      • Trial / Protocol Design
      • Trial Conduct & Management
      • Investigator Selection: Who can be an Investigator?
      • Sponsor Monitoring (See allocated time below)
  • Lunch Break
  • Ethics & Research Subject Protection
    • History of research ethics
    • Human Subject protection
    • Risk assessment
  • Investigator Responsibilities:
    • Qualifications & Agreements
    • Resources & Selection of the trial team: delegation, Log of study Personnel, Keeping members informed
    • Medical Care of trial subjects
    • Compliance with the protocol
  • Quality Assurance / Quality Control in Clinical Trials
    • Defining the terminology
    • The quality challenges
    • The quality plan / Operational QC
    • Role of Clinical Quality Assurance: What should you expect from Clinical Quality Assurance (CQA)?
    • GCP Audits: what you need to know
  • Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management
    • What is non-compliance?
    • Most common inspection & audit findings
    • Identifying the root cause
    • Corrective Action versus Preventative Action
    • What is NOT a good CAPA?
  • Ethics for Genetics Research
  • Informed Consent: The how? What? & why?
  • Investigational Medicinal Product & Drug Accountability
  • Safety Reporting:
    • Protocol requirements pertaining to safety
    • Expedited reporting of adverse events (AEs).
    • What makes a well-documented adverse event (AE).
    • What is a Suspected Unexpected Adverse Reaction (SUSAR).
    • Laboratory Evaluations
  • Day Two (8:30 AM – 4:30 PM)
  • 09.00 AM - Session Start Time
  • Drug Safety Monitoring Board (DSMB)/Independent Drug Monitoring Committee (IDMC) Clinical Trial Safety and Safety Monitoring
    • Background & GCP Guidelines for DSMB/IDMC
    • What are the processes of DSMB/IDMC Review?
  • Sharing Best Practice in Patient Recruitment & Subject retention
    • Subject Recruitment:
    • Recruitment prediction,
    • Advertising,
    • Avoiding pitfalls.
  • Lunch Break
  • Essential Documents To Ensure A Complete TMF Under All Regulations
    • Regulators’ Focus on TMF: Why?
    • Why should sponsors Focus on TMF?
    • Common Audit/Inspection TMF-related findings
    • Lessons learnt………. Or…. Not!
  • Data Quality and Archive
  • Meet Your Instructor

    Amer Alghabban
    Amer Alghabban
    Managing Director, GxP Compliance and Training Partners (GCTP)

    Amer Alghabban, M.Sc. (Clin. Pharmacology), Post-Grad. Cert. Clinical Research, Dipl. Bio. Sci., B.Sc., Cert. Teacher Education, M Soc. Pharm. Med., MRQA, MIQA, MDIA, ISO 9001:2015 QMS Certified Lead Auditor, IRCA Certified Lead Auditor.

    Amer is currently the Managing Director of GxP Compliance and Training Partners (GCTP), which he founded, helping pharmaceutical companies & academic institutions worldwide to achieve compliance with GCP, GVP, GCLP, GDP and GLP.

    Amer, a Clinical pharmacologist by education, has over 28 years’ experience in the pharmaceutical industry. He enjoys imparting his experiences, as an invited speaker at over 125 international congresses and as writer; he published 2 reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. Amer has experience of working at the MHRA where he participated in the conduct of the very first Regulatory Authority pharmacovigilance-GCP inspection in the EU and wrote the 1st EU regulatory authority SOPs on conducting GVP inspections. He has over 21 years’ experience of directing Inspection Readiness Programs (Mock Inspections & Pre- & Post-Mock Inspection-Training) and hosting regulatory authorities’ & notified bodies’ inspections. To date, he has prepared, trained, hosted & managed over 67 Regulatory Authorities’ inspections by all major regulatory authorities (FDA, EMA, EU Authorities (CAs), Japanese PMDA, Brazilian, Chinese SFDA & Middle Eastern authorities etc.) Earlier in his career, he was Assistant Editor for 11 medical journals and was the 1st invited Course Director for The Pharmacovigilance Auditing Course at the RQA.

    Amer’s other previous positions included: Vice President GxP Quality Assurance, Compliance & Training at Karyopharm Therapeutics Inc. Boston, USA, Global Director, Head of Quality Assurance at Merck Serono, Geneva, Switzerland, Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.

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